Carboxy Therapy Applicator

ABSTRACT

Handheld carboxy therapy applicators are disclosed. In one implementation, a handheld carboxy therapy applicator includes a heater module, a humidification module, and a hypodermic needle. The heater module is configured to receive a flow of gas and to warm gas within the flow of gas. The humidification module is in fluid communication, such as in a serial connection, with the heater module. The humidification module is configured to receive the flow of gas from the heater module and to humidify the gas within the flow of gas. The hypodermic needle is in serial connection with the humidification module. The hypodermic needle is configured to receive the flow of gas from the humidification module and to inject the flow of gas into a tissue of a patient.

RELATED APPLICATION

The present application is a continuation of U.S. patent applicationSer. No. 15/906,684 (still pending), filed Feb. 27, 2018, which is acontinuation of U.S. patent application Ser. No. 14/823,529 (now U.S.Pat. No. 9,937,304), filed Aug. 11, 2015, which is a continuation ofU.S. patent application Ser. No. 13/619,310 (now U.S. Pat. No.9,132,245), filed Sep. 14, 2012, which claims priority to U.S.Provisional Patent Appln. No. 61/535,613, filed Sep. 16, 2011, theentirety of each of which are hereby incorporated by reference.

BACKGROUND

Under carboxy therapy, carbon dioxide is infused into human tissue fortherapeutic purposes, including, without limitation, for reducingstretch marks; reducing cellulite; firming sagging tissues around theneck or buttocks; and reducing wrinkled skin around the eyes andbreasts. The basis for the treatment is that carbon dioxide is injectedbeneath the surface of the skin to cause the body to interpret the cellstructure as having an oxygen defect. The body responds by trying toincrease blood flow and growth factors or vascular endothelial growthfactors (VEGF) in the affected area, thereby encouraging collagen growthand/or causing the body to attack fat tissue.

Currently available carboxy therapy products heat gas at a control unit.While the gas may be heated as it leaves the control unit, the gas maycool to ambient room temperature as it travels through a tube or aseries of tubes from the control unit to a hypodermic needle where thegas is injected into the patient. Accordingly, there is a need forimproved carboxy therapy products that are able to provide warmed gasesto a patient.

BRIEF DESCRIPTION OF SEVERAL VIEWS OF THE DRAWINGS

FIG. 1 is an exploded view of one implementation of a carboxy therapyapplicator.

FIG. 2 is a cross-sectional view of the applicator of FIG. 1.

FIG. 3 is an exploded view of another implementation of a carboxytherapy applicator.

FIG. 4 is a cross-sectional view of the applicator of FIG. 3.

FIG. 5 is an exploded view of another implementation of a carboxytherapy applicator.

FIG. 6 is a cross-sectional view of the applicator of FIG. 5.

FIG. 7 is an exploded view of another implementation of a carboxytherapy applicator.

FIG. 8 is a cross-sectional view of the applicator of FIG. 7.

FIG. 9 is an exploded view of another implementation of a carboxytherapy applicator.

FIG. 10 is a cross-sectional view of the applicator of FIG. 9.

FIG. 11 is an exploded view of another implementation of a carboxytherapy applicator.

FIG. 12 is a cross-sectional view of the applicator of FIG. 11.

FIG. 13 is an exploded view of another implementation of a carboxytherapy applicator.

FIG. 14 is a cross-sectional view of the applicator of FIG. 13.

FIG. 15 is a flow chart of a method for performing carboxy therapy.

FIG. 16 is a diagram of a controller that may be used in carboxytherapy.

DETAILED DESCRIPTION OF THE DRAWINGS

The present disclosure is directed to improved carboxy therapyapplicators that are able to provide a desired gas, including, withoutlimitation, carbon dioxide, at a desired flow rate, warmed and/orhumidified and/or otherwise conditioned or treated, to a patient forsubcutaneous cosmetic purposes. The gas is preferably provided at arange of temperatures being close to body temperature, from 95 to 105degrees Fahrenheit. Other temperatures ranges may be suitable dependingon the particular application, including, without limitation, 75 to 95degrees Fahrenheit. In some implementations, the desired gas flow rateis within the range of 20 to 150 milliliters per minute. Additionally,the disclosed carboxy therapy applicators, control box, and/orinsufflator allow a user, such as a physician, to condition and/or treatthe gas and control gas flow, gas pressure, gas temperature, gashumidity, the pH level, and other parameters.

FIG. 1 is an exploded view of one implementation of a carboxy therapyapplicator 100 and FIG. 2 is a cross-sectional view of the applicator100 of FIG. 1. The carboxy therapy applicator 100 may include a handpiece 102, a humidification module 104, a heater module 106, and ahypodermic needle 108.

As described in more detail below, the carboxy therapy applicator 100 isconfigured such that the heater module 106 receives a flow of gas from acontrol unit, an insufflator, and/or any other gas source that mayprovide gas to a tubing at a predetermined pressure and/or flow rate. Insome implementations the heater module 106 receives gas from acontroller that is distinct from an insufflator, where in otherimplementations, the heater module 106 receives gas from a controllerthat is integrated with an insufflator. The gas is warmed in the heatermodule 106 and then flows into the humidification module 104 positionedin fluid communication, such as in a serial connection, with the heatermodule 106. Within the humidification module 104, the warmed gas ishumidified before the gas flows into the hypodermic needle 108 in serialconnection with the humidification module 104. The gas then flows out ofthe hypodermic needle 108 and into the tissue of the patient. It will beappreciated that in other implementations, rather than warming and thenhumidifying the gas, the gas is warmed and humidified simultaneously.Examples of general system that may be suitable to warm and humidify gassimultaneously may be found in U.S. Pat. No. 7,762,251, the entirety ofwhich is hereby incorporated by reference.

Because the flow of gas is warmed and humidified within the carboxytherapy applicator 100 immediately before it is injected into the tissueof the patient, the carboxy therapy applicator 100 is able to provideheated, humidified gas to a patient for subcutaneous cosmetic purposesat a range of temperatures close to body temperature from 95 to 105degrees. Providing warmed, humidified gas to the tissue of the patientreduces drying of the tissue that may cause the patient pain.

As shown in FIG. 1, gas flowing from a control unit, an insufflator,and/or another gas source may enter the heater module 106 via tubing 110and a gas filter 112. In some implementations the gas may include carbondioxide. However, other gases may be used. The gas may flow into theheater module 106 at a first end and flow into an interior region 114 ofthe heater module 106. A heater cartridge 116, that receives power froma wire 117, is positioned within the interior region 114 of the heatermodule 106 and warms the gas before the warmed gas exits the heatermodule 106 at a second end of the heater module 106. As the warmed gasexits the heater module 106, it enters the humidification module 104that is positioned in serial connection with the heater module 106. Insome implementations, the heater module 106 is threadably connected tothe humidification module 104.

The humidification module 104 may include a hydrophilic filter 118, ahumidification medium 120, one or more semi-permeable membranes 122,123, a humidifier cap 124, and an injection port 126. In someimplementations, the components of the humidification module 104 may bepositioned within an interior region 128 of the hand piece 102.

As the warmed gas enters the humidification module, it may pass througha first semi-permeable membrane 122. The semi-permeable membrane 122allows gas to enter the humidification module 104 while preventing otherimpurities and articles from entering the humidification module 104 fromthe heater module 106. The gas flow passes over and/or through thehumidification medium 120 and absorbs moisture. In some implementationsthe gas flow may absorb only water vapor from the humidification medium120, where in other implementations, the gas flow may absorb one or moreother medications, chemicals, and liquids, such as sodium bicarbonate,in addition to water vapor. For example in some implementations,hydrogen peroxide (H₂O₂) is used with the humidification medium 120 forthe purpose of adding oxygen to the gas as it passes through thehumidification module 104.

Liquids may be introduced into the humidification module 104 and thehumidification medium 120 using the injection port 126. In someimplementations, the injection port 126 may be connected to a controllerthat controls the amount of liquid introduced into the humidificationmodule 104 over a period of time.

After passing over and/or through the humidification medium 120, the gasflow passes through the hydrophilic filter 122 to filter impurities suchas particulate matter or bacteria from the gas flow. Before entering thehypodermic needle 108 connected in series with the humidification module104, the gas flow passes through a second semi-permeable membrane 123 toprevent any liquids from entering the hypodermic needle 108 from thehumidification module 104 and being directly injected into a patient.The second semi-permeable membrane 123 may also serve to block any bodyfluids that enter the hypodermic needle 108 when inserted into humantissue from entering the humidification module 104.

In some implementations, the hypodermic needle 108 is positioned in thecarboxy therapy applicator 100 immediately after the humidificationmodule 104 so that there is no loss between the gas flow exiting theheater module 106 and the humidification module 104 and entering thehypodermic needle 108 that is penetrating the skin of the patient.

The carboxy therapy applicator 100 may include one or more switches 130and a display 134. The one or more switches 130 allow a physician usingthe carboxy therapy applicator 100 to easily control the gas flow andthe display 134 provides information regarding the gas flow, such asindications of a gas flow rate, a temperature of the gas within the gasflow, a pH level of the gas within the gas flow, and/or a relativehumidity level of the gas within the gas flow.

In some implementations the one or more switches 130 may be membraneswitches. However, it will be appreciated that other types of switches130 may also be used. When the one or more switches 130 are membraneswitches, due to the small nature of a membrane switch, multipleswitches 130 may be placed on the hand piece 102 in close proximity toeach other. The switches 130 may be of varying heights to create tactiledifferentiation between the switches 130 so that any of the one or moreswitches 130 may be identified by feel.

In some implementations, activation of a switch 130 may cause a signalto be sent to the control unit, insufflator, and/or other gas source tostart or stop the flow of gas. In other implementations, multipleswitches 130 may be used to send signals to the control unit,insufflator, and/or other gas source to increase or decrease the flow ofgas. For example, a first switch 130 positioned on the hand piece 102may create a signal to cause the control unit to increase the flow ofgas and a second switch 130 positioned on the hand piece 102 may createa signal to cause the control unit to decrease the flow of gas.

In addition to controlling the flow of gas, switches 130 may also bepositioned on the hand piece 102 to send a signal to the control unit,insufflator, and/or other gas source to adjust a pressure of the gasflow and/or switches 130 may be positioned on the hand piece 102 tocontrol the temperature of the heater cartridge 116 of the heater module106. In some implementations, switches 130 on the hand piece 102 may beused in combination to provide various control signals to the controlunit, insufflator, and/or other gas source.

When activated, the switches may cause the carboxy therapy applicator100 to send one or more control signals to the control unit,insufflator, and/or other gas source via means such as a hardwire 132that is connected to the control unit, insufflator, and/or other gassource, or via wireless means that utilize infrared (IR) signals orradiofrequency (RF) signals to communicate with the control unit,insufflator, and/or other gas source.

It will be appreciated that by placing the switches 130 on the handpiece 102 of the carboxy therapy applicator 100, a physician is able toeasily adjust important parameters for a procedure, such as gas flow,volume pressure, and gas temperature, without going back to thecontroller or using external applicators such as a foot pedal. Byadjusting factors such as gas flow, volume pressure, and/or gastemperature, a physician is able to adjust the amount of humidificationand the pH level of the gas as it is injected into the tissue of thepatient.

For example, the temperature of the gas flow as it passes through thehumidification module 104 affects the relative humidity of the gas. Athigher temperatures, the rate (or amount) of evaporation of the liquidwithin the humidification module 104 is high resulting in a highrelative humidity of the gas. Alternatively, at lower temperatures, therate (or amount) of evaporation of the liquid within the humidificationmodule 104 is low resulting in a low relative humidity of the gas.

Further, the flow rate of the gas as it passes through thehumidification module 104 affects the relative humidity of the gas. Thelonger a unit of gas is in the humidification module 104, the morelikely the unit of gas is to absorb moisture within the humidificationmodule 104. Accordingly, increasing the gas flow rate through thehumidification module 104 typically results in a decrease in therelative humidity of the gas. Alternatively, decreasing the gas flowrate through the humidification module 104 typically results in anincrease in the relative humidity of the gas.

When a solution with a highly acidic pH level or a solution with ahighly basic pH level is used in the humidification module 104, it willbe appreciated that adjusting the gas flow or gas temperature to adjustthe relative humidity of the gas will also affect the pH level of thegas. For example, when a solution with a highly acidic pH level is usedin the humidification module 104, increasing the relative humidity ofthe gas will result in a decrease of the pH level of the gas anddecreasing the relative humidity of the gas will result in an increaseof the pH level of the gas. Similarly, when a solution with a highlybasic pH level is used in the humidification module 104, increasing therelative humidity of the gas will result in an increase in the pH levelof the gas and decreasing the relative humidity of the gas will resultin a decrease of the pH level of the gas.

For example, when the relative humidity of a gas flow containing carbondioxide is increased, carbon dioxide will often break down into carbonicacid. As discussed above, the formation of carbonic acid is human tissuecan result in increased cellular activity and/or increased pain to apatient. In order to decrease the level of acidity when the gas flow isinjected into the tissue of the patient and decrease the likelihood ofcarbonic acid forming in the tissue, solutions with different pH levelsmay be introduced into the humidification medium. In someimplementations, solutions comprising between 7.5% sodium bicarbonateand 8.4% sodium bicarbonate may be used to decrease the acidity level ofthe gas.

In some implementations, the applicator 100 or the control box mayinclude a pressure safety valve positioned between the humidificationmodule 104 and the hypodermic needle 108. The pressure safety valveprevents any over pressurization by providing pressure relief at theterminus of the connection to the hypodermic needle 108. In someimplementations, the pressure safety valve may control the pressure inthe sub-dermal pouch to a range from 1 mmHg to 150 mmHg, with an optimalrange, depending on the location of the body, of between 1 mmHg and 50mmHg, and flow rates from 1 ml per minute to 500 ml per minute.

In some implementations, the applicator 100 may further include a carbondioxide detector configured to monitor carbon dioxide levels of the areaaround a patient and physician. Side effects of carbon dioxide mayinclude drowsiness, confusion, nausea, and create the potential foradverse conditions for the physician or patient. The applicator maymonitor the area to determine if carbon dioxide levels, either generatedfrom the procedure, the equipment, or leaks from the carbon dioxidesource, are large enough to create a hazard in the working environment,and indicate a potential hazard on the display 134 of the applicator.

Further implementations of carboxy therapy applicators are illustratedin FIGS. 3-14. In the implementation illustrated in FIGS. 3 and 4, thehumidification module 304 includes a semi-permeable membrane 322positioned to block liquids from flowing into the hypodermic needle 308.However, the implementation does not include a semi-permeable membranepositioned between the humidification module 304 and the heater module306.

In the implementation illustrated in FIGS. 5 and 6, the humidificationmodule 504 does not include a semi-permeable membrane positioned toblock liquids from flowing into the hypodermic needle 508. Theimplementation also does not include a semi-permeable membranepositioned between the humidification module 504 and the heater module506.

In the implementation illustrated in FIGS. 7 and 8, the carboxy therapyapplicator includes one or more aerosol ports 736. Each aerosol port 736is configured to allow a physician to insert an aerosolized medicamentsuch as anti-inflammatories or pain medication into the gas flow. Theaerosolized port 736 is typically positioned in the applicator such thatthe aerosolized medicament is inserted into the gas flow shortly beforethe gas flows into the hypodermic needle 708. However, the aerosolizedport 736 may be positioned at other locations in the applicator toinsert an aerosolized medicament into the gas flow.

In the implementation illustrated in FIGS. 9 and 10, the applicator doesnot include a heater module. Instead, the gas flows from the controlunit directly into the humidification module 704. After absorbingmoisture within the humidification module 704, the gas flows into thehypodermic needle 708 for insertion into the tissue of the patient.

In the implementation illustrated in FIGS. 11 and 12, the applicatordoes not include a humidification module. Instead, the hypodermic needle1108 is serially connected to the heater module 1106. Accordingly, afterthe gas is heated within the heater module 1106, the gas flows into thehypodermic needle 1108 for insertion into the tissue of the patient. Inthese implementation, the applicator may include a port such as thosedescribed above that are configured to receive water vapor, liquids,aerosolized medicaments, and/or chemical, and insert the receivedsubstance into the gas flow before the gas flows into the hypodermicneedle 1108.

In the implementation illustrated in FIGS. 13 and 14, the applicatorincludes a sensor 1338 to measure a property of the gas before it entersthe hypodermic needle 1308. For example, the sensor 1338 could be usedto measure one or more of the relative humidity of the gas, thetemperature of the gas, the pressure of the gas, the flow rate of thegas, the pH level of the gas, or the carbon dioxide level of the gas. Insome implementations, information regarding the property of the gasdetected by the sensor 1338 is provide on the display 1334 of theapplicator.

FIG. 15 is a flow chart of a method for providing carboxy therapy to apatient using implementations of the carboxy therapy applicatordescribed above. The method begins at 1502 with the carboxy therapyapplicator receiving a gas flow from a controller, an insufflator,and/or another gas source. In some implementations the gas comprisescarbon dioxide. However, in other implementations the gas may compriseother types of gases or combination of gases in various percentages. Oneexample of a mixed-gas insufflator system that may be used with thepresent application is described in U.S. Pat. No. 7,654,975, theentirety of which is hereby incorporated by reference.

At step 1504, the gas flows into a heater module of the applicator andis warmed at step 1506. The warmed gas flows out of the heater module ofthe applicator and into a humidification module 1508. Within thehumidification module, the gas flows over and/or through ahumidification medium and absorbs moisture at step 1510. In someimplementations, the gas absorbs water vapor only as the gas flows overand/or through the humidification medium, where in otherimplementations, the gas absorbs water vapor and other medicaments suchas sodium bicarbonate as it flows over and/or through the humidificationmedium. After absorbing moisture, the gas flows through a semi-permeablemembrane at step 1512 to block liquids from exiting the humidificationmodule.

At step 1514, a sensor in the carboxy therapy applicator measures one ormore properties of the gas, and at step 1516, information relating tothe one or more properties measured by the sensor is displayed on adisplay of the carboxy therapy applicator. In some implementations thesensor may measure properties of the gas such as the relative humidityof the gas, the temperature of the gas, pressure of the gas, the flowrate of the gas, the pH level of the gas, or the carbon dioxide level ofthe gas.

At step 1518, a physician may activate one or more switches on thecarboxy therapy applicator. In response, at step 1520, the carboxytherapy applicator may perform operations based on the activatedswitches such as sending a signal to a control unit to start a gas flow,stop a gas flow, decrease a flow rate of the gas, increase a flow rateof the gas, increase a pressure of the gas, or decrease a pressure ofthe gas. The carboxy therapy applicator may additionally perform actionsbased on the activated switches such as increasing or decreasing atemperature of a heating cartridge of the heating module of the carboxytherapy applicator to change a temperature of the gas flowing throughthe applicator.

At step 1522, an aerosolized substance or a liquid may be inserted intothe gas flow via a port in the applicator. The aerosolized substance orliquid may be water vapor, an aerosolized medicament, a substance tochange a pH level of the gas, or any other substance that a physicianmay wish to insert into the gas flow before the gas is injected into atissue of the patient.

The gas may flow across a pressure valve at step 1524, where thepressure valve may release gas from the carboxy therapy applicator whenthe pressure of the gas flow exceeds a predetermined threshold.

At step 1526, the gas flows into a hypodermic needle of the applicator,and at step 1528, the gas is injected into a tissue of a patient. Atstep 1530, a carbon dioxide sensor may monitor a carbon dioxide levelaround the patient and the physician, and at step 1532, information fromthe carbon dioxide sensor is provided on the display of the applicator.

FIG. 16 is a diagram of a controller 1600 that may be used in carboxytherapy. While the controller 1600 illustrated in FIG. 16 may be shownas part of a gas delivery apparatus, such as an insufflator, it shouldbe appreciated that in other implementations the controller 1600 may bedistinct from the gas delivery apparatus and be located in a controlbox, one of the carboxy therapy applicators described above with respectto FIGS. 1-15, or in any other part of the gas delivery system.

Traditional laparoscopic insufflators are generally high flow rate,pressure controlled devices. However, in dermatological applications, itis desirable to control a flow rate, pressure, and volume ofsubcutaneous injection of a gas such as CO₂. Further, due to the use ofneedles in carboxy therapy that are typically smaller in size, on theorder of approximately 28 to 30 gauge, than those utilized withtraditional laparoscopic insufflators, the need to control flow rates,volume, and pressure of a gas is more significant than in traditionallaparoscopic insufflators.

During operation, the controller 1600 measures and adjusts a flow rate,pressure, and/or volume of a gas to account for variations in tissue anda desired affect of the injected gas. For example, subcutaneousinjection of gas for wrinkle applications may require control of smallamounts of gas volume (as low as 5 ml) at relative flow rates between 5to 20 ml per minute, and at a pressure of between 5 to 30 mmHg. Thecontroller may monitor and adjust the flow rate, pressure, and/or volumeof a gas to stay within these parameters.

The controller 1600 of FIG. 16 includes a microprocessor control unit1602, a primary regulator 1604, a secondary regulator 1606, a pressurerelease valve 1608, a pressure switch 1610, a monitor port 1612, afilter 1614, a control valve 1618, a pressure sensor 1620, a precisionorifice 1622, a flow detector 1624, and a blow-off valve 1626. However,it will be appreciated that in other implementations, the controller1600 may not include all elements shown in FIG. 16.

In some implementations, the microprocessor control unit 1602 may be incommunication with the pressure switch 1610, the control valve 1618, thepressure sensor 1620, the precision orifice 1622, and the flow detector1624, as well as a carboxy applicator such as one of the applicatorsdescribed above with respect to FIGS. 1-15. The controller 1600 utilizesthe microprocessor control unit 1602 to control flow rate, pressure,and/or volume of a gas flow through the use of the variable controlvalves and orifices, pressure sensing sensors, and a timed sequence ofvalve activation to allow for the selection of a volume amount, a flowrate, and a not to exceed pressure.

For example, controller 1600 may operate the control valve 1618 to bealternatively open and closed to allow the flow path to equalize for thepurpose of taking a pressure reading, and then reopening to fulfill thedesired selected volume. Because of the severe restriction caused by thesmall gauge needles required for procedures such as carboxy therapy, thepressure measurements require longer delays to allow for proper settlingtime. In this instance, the delay time is greater than 250 microseconds,as compared to endoscopic insufflator controllers that are generallysignificantly less than 250 microseconds.

The controller 1600 may further include a CO₂ detector 1628 incommunication with the microprocessor control unit 1602 that can monitora level of CO₂ gas at an operative area such as a working environment.As more procedures using insufflation and CO₂, such as laparoscopy,virtual colonoscopy, endoscopy, and carboxy therapy, move out of anoperating room environment, the work environments where insufflation andCO₂ are used may not be optimized for proper air exchange to prevent abuildup of CO₂ in a location where a procedure is performed. The effectsof exposure to CO₂ may include drowsiness, confusion, and nausea, andcreate the potential for adverse conditions for an operator performing aprocedure or a patient that is receiving the procedure. The controller1600 may also include the CO₂ detector 1628 to monitor a workingenvironment where a procedure using CO₂ is performed to determine if CO₂levels, either generated from the procedure, the equipment, or leaksfrom the CO₂ source, are large enough to create a hazard in the workingenvironment, and indicate a potential hazard.

FIGS. 1-15 illustrate various implementations and methods for a carboxytherapy applicator to provide warmed, humidified gas to a patient forsubcutaneous cosmetic purposes. Additionally, the disclosed carboxytherapy applicators provide a physician the ability to easily controlparameter of gas flow, gas pressure, gas temperature, and pH leveldirectly from the applicator. FIG. 16 illustrates a diagram of acontroller that may be used in carboxy therapy in conjunction with a gasdelivery apparatus, such as an insufflator, and an applicator such asthose described in conjunction with FIGS. 1-15.

The embodiments of the invention disclosed herein are presentlyconsidered to be preferred, various changes and modifications can bemade without departing from the spirit and scope of the invention. Asnoted, the discussion above is descriptive, illustrative and exemplaryand is not to be taken as limiting the scope defined by any appendedclaims, and all changes that come within the meaning and range ofequivalents are intended to be embraced therein.

What is claimed is:
 1. A handheld carboxy therapy applicator comprising:a heater module configured to receive a flow of gas and to warm gaswithin the flow of gas; a humidification module in fluid communicationwith the heater module, the humidification module configured to receivethe flow of gas from the heater module and to humidify the gas withinthe flow of gas; and a hypodermic needle in serial connection with thehumidification module, the hypodermic needle configured to receive theflow of gas from the humidification module and to inject the flow of gasinto a tissue of a patient at a rate between 20 and 150 milliliters perminute.